Medical Safety Leader (Executive or Senior Director)

Ailux; Boston (MA); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

AiLux is seeking a Medical Safety Leader (U.S.-based) to own the integrated medical safety strategy for biologics and oral therapies targeting immune-mediated diseases. You will translate nonclinical and clinical data into clear safety narratives, oversee surveillance, risk management, and regulatory interactions, and shape governance across the portfolio.

Lead cross-functional teams in safety strategy from candidate selection through early human trials, daily pharmacovigilance operations, and

Formación

• MD or MD-PhD with clinical training in immunology or related fields.
• 5–7+ years in biotech/pharma medical safety, pharmacovigilance, or clinical development.
• Experience leading safety from preclinical through PoC and beyond.
• Global PV regulations knowledge (FDA, EMA, NMPA).

Responsabilidades

• Develop integrated medical safety strategy across portfolio.
• Direct safety surveillance and signal management.
• Oversee medical review of aggregate reports (DSURs, PSURs, RMPs).
• Represent safety to executives, DSMBs, health authorities, and partners.

Conocimientos

Medical safety

Pharmacovigilance

DSUR PSUR

Regulatory knowledge

Cross-functional leadership

Educación

MD or MD-PhD

Descripción del empleo

Ailux is an innovative biotechnology company harnessing AI to accelerate breakthrough biologic therapies in difficult immune-mediated diseases and improve the lives of patients with significant unmet medical need. Built on intelligent design and guided by people who care about transforming healthcare, our technology is redefining what is possible in biologics development, from how we select targets to how we engineer the molecules.Ailux’s vision is to light the path to new cures and fundamentally change our approach to science and drug development to redefine current treatment paradigms. We look to continue unlocking the potential of disease biology, integrate AI-enabled biologics development, and deliver effective clinical execution.Backed by an experienced leadership team, leading scientific advisors, a highly multidisciplinary organization, and strategic partnerships in biopharma, Ailux is approaching a key inflection point as its first wave of therapeutic programs advance toward clinical development. This is an opportunity to play a vital role in leading programs from pre-clinical development into the clinic and through clinical proof-of-concept, shaping the pipeline and development culture of a rapidly growing biotechnology company.

Role Overview

The Medical Safety Leader (U.S.-based) is accountable for the integrated medical safety strategy, scientific leadership, and oversight of the company’s portfolio of biologics and oral therapeutics targeting immunology, inflammation, and immune-mediated diseases. This leader will direct safety strategy from candidate selection and IND/CTA-enabling activities through first-in-human, proof-of-mechanism, proof-of-concept, and later-stage development as programs mature. The role requires deep expertise in clinical safety and pharmacovigilance, strong medical judgment, and the ability to translate emerging nonclinical and clinical data into clear benefit–risk assessments, risk‑management actions, and development decisions. The Medical Safety Leader will establish rigorous standards for safety surveillance, signal detection and management, aggregate reporting, safety governance, and regulatory compliance across the portfolio.

Working through cross-functional development teams, the Medical Safety Leader will provide unified medical safety leadership, integrating clinical, nonclinical, translational, biomarker, regulatory, CMC, operational, and commercial considerations into coherent product safety strategies. These strategies will define safety objectives, key risks, monitoring plans, decision criteria, mitigation measures, and evidence requirements; support timely, data-driven decisions at governance milestones; and ensure that patient safety remains central throughout development.

The Medical Safety Leader will influence functions and geographies and may build or oversee safety and pharmacovigilance capabilities as the portfolio grows. They will set accountabilities, assessment and documentation standards, escalation, and execution. Partnering with Clinical Development and Operations, the leader will shape protocols, eligibility, monitoring, dose escalation, adverse‑event management, data review, and trial conduct while owning safety strategy, signal evaluation, benefit–risk assessment, risk management, and interpretation. The role collaborates across scientific, clinical, regulatory, operational, quality, and business functions; represents safety in governance, health‑authority, and partner forums; and reports to the Chief Medical Officer.

Key Accountabilities & Responsibilities

1. Strategy & Pre-clinical Safety

• Global Strategy: Lead medical safety strategy, benefit-risk assessments, and cross-functional safety governance from candidate selection through lifecycle management.
• Pre-clinical Translation: Translate nonclinical toxicology, pharmacology, and exposure-response data into FIH starting doses, safety margins, stopping rules, and IND/CTA safety sections.
• Protocol Safeguards: Review clinical protocols, IBs, and ICFs to embed dose-escalation safeguards, eligibility criteria, and monitoring cadence.

2. Clinical Safety & Pharmacovigilance

• Surveillance & Signal Detection: Direct continuous safety surveillance (AEs, AESIs, lab trends, immunogenicity, modality risks) and lead signal management through resolution.
• Medical Review & Aggregate Reports: Oversee medical case reviews (causality, seriousness) and lead medical input for aggregate reports (DSURs, PSURs/PBRERs, RMPs, RSI, and labeling).
• PV Operations & Vendors: Govern external PV service providers to ensure case quality, reporting compliance, and operational execution.

3. Stakeholder Management & Quality

• Governance & Representation: Serve as primary medical safety expert to executive leadership, DSMBs, health authorities (FDA, EMA, NMPA), and external partners/KOLs.
• BD Support: Evaluate safety liabilities and benefit‑risk profiles for partnering, licensing, and due diligence.
• Compliance & Infrastructure: Ensure compliance with global PV regulations (ICH‑GCP) and scale internal PV infrastructure, SOPs, and SDEAs.

Experience & Skills

• Education: MD or MD-PhD (or equivalent) with clinical training in immunology, inflammation, or related fields.
• Experience: 5–7+ years in biotech/pharma medical safety, pharmacovigilance, or clinical development, with demonstrated safety leadership from preclinical/FIH through PoC and beyond.
• Technical Mastery: Deep expertise in medical review, signal detection, safety databases, aggregate reporting (DSUR/RMP), and global PV regulations (FDA, EMA, NMPA).
• Cross-Functional Governance: Track record of governing PV vendors, integrating multi-disciplinary data (CMC, Tox, PK/PD), and leading health authority interactions.
• Experience in immunological conditions (dermatology, rheumatology, gastroenterology, respiratory).
• Background managing safety for biologics (antibodies, multispecifics) and oral therapeutic modalities.
• Global development experience spanning the US, China, and Europe.
• Experience with SDEAs, licensing due diligence, or scaling PV capabilities in a growing biotech.

Leadership Profile

A decisive medical leader who integrates case-level data with portfolio strategy, navigates complex risk‑benefit decisions under uncertainty, and embeds a rigorous, patient-centered safety culture across the drug lifecycle.